Thursday, 29 November 2007

Part TWO: WADA laboratory to standardize...


In the body of the CODE...

(Part ONE of this two part essay dealt with the situation of legal imbalance, as established in the documents that created the World Anti-Doping Agency, its CODE and International Standard for Laboratories.

Focus on these imbalances led to this blog: WADAwatch, and an eight-page Questionnaire for Labs. The starting basis of analysis, consisted simply of agreeing with WADA that standardization and harmonization must begin with the laboratories that have been 'honoured' with the title of "WADA accredited".)


In the body of the CODE...

Since its inception, WADA has not laid out a proper legal path that would hold the accredited Laboratories to simple performance of their legal duties.


Simply put, WADA laboratories must perform nothing less than 100 per cent supportable scientific tests, that display penultimate reliability, reproducibility and consistency, so as to avoid ambiguities that result in loss of scientific credibility.


The mistaken path began with Article 3.2.1; WADA granted its laboratories a 'presumption' that their work as to Sample analysis and Custodial procedures would comply with the ISL, while the Athlete could rebut that by establishing that a departure from the ISL occurred.


The failure-factors here are associated with the inequity of a shield being offered, through which a laboratory could hide any malicious agenda, incompetence, or worse failures, while affecting an Athlete's livelihood. WADA appears not to grasp how this failure also carries augmented legal costs that any accused Athlete must bear, to overcome the presumption and the subsequent burden-shifting(s).


Although WADAwatch is convinced that the best purposes of WADA would be upheld only through parallel application of the 'strict liability' rule to both Athletes and laboratories, a CAS arbitrator in Madrid supported the presumption unconditionally, commenting that “you couldn't operate without that presumption”.


WADAwatch remains unconvinced that this is so, especially if removal of the presumption forced more intense efforts to do cleaner science in these labs.


But Article 3.2.1 is only the tip of the iceberg.


In Article 6.4, the CODE mandates (“shall”) its labs to follow the ISL. Remember that 3.2.1 already stipulated the presumption that this had occurred in particular cases (Article 3 being concerned with 'proof of doping'; sub-Article 3.2 concerns establishment of facts and presumptions).


Thus there exists the paradox that a presumption is granted to a laboratory in 3.2.1 that it did perform analysis and custodial duties according to the ISL, prior to its receiving the duty (shall analyze in conformity), as expressly granted (in 6.4).


In most legal works, such as treaties or this WADA CODE, it is desirable to establish a duty (shall analyze in conformity), prior to offering a presumption that work performed subsequent to this grant (and accreditation!) has been presumably performed in conformity.


The reasoning, which underlies the paradoxal 3.2.1. presumption, fails emphatically as we pass from Article 6.4 to Article 7.1 and 7.2.

Newly-modified, this Article on Results Management prescribes regulations for the proper management of confidential testing results. In its relevance to this discussion, it is timely to ponder why WADA moved away from its reasonable wording “...any apparent departure... that undermined the validity” toward “...any apparent departure... that caused” the AAF. There are no notes that indicate the substantive reason for changing this.


Legally speaking, it is quite a farther leap in the legal arts, to prove that an apparent departure 'caused' an AAF, than to prove that the apparent departure 'undermined the validity'. In choosing this variation, WADA and its Signatories appear to be distancing themselves from conceding a possibility of laboratory incompetence.


As one example, a severely flawed Chain of Custody document could seriously impact the validity of an AAF result, but unless the Athlete can PROVE that the flawed document concealed a laboratory's replacement of his or her sample with that of another competitor (negligently or through... sabotage?) there is little chance to prove that it 'caused' the AAF.


Thus might one surmise that WADA is redrafting its rules simply to win more cases? IF on bad scientific methodology (to a level that would have severe consequences for a lab's accreditation) and poor rules, an empire is made, so be it...


However therein lies a greater debacle, if one reads Article 7.1 & 7.2 carefully.

Simply described: WADA, via Article 6.4, holds labs to high standards of performance. Upon receiving results (worthy of leaking?) at an Anti-doping Organization (ADO), Article 7.1 tells that ADO to analyze the positive A sample results of the lab, to ensure that (among other things) no “... apparent departure... caused” the AAF.


And, having ensured that (if such be the case) no apparent departure had caused the AAF, the ADO rightly should inform the Athlete as to the situation, and his or her rights for B Sample confirmation testing. This creates such an obvious void that one is hard-pressed to understand how WADA's Signatories avoided this for four years.


PROBLEM ONE:
There is no statement in CODE Article 7, as to the procedures to follow when an ADO does find an apparent departure that caused the AAF. As well, or at least, there exists no reference to ISL Article 5.3.8, which expresses procedures for 'complaints of nonconforming testing work' pursuant to the ISO/IEC 17025:2005 Section 4.8 (without naming potential parties, as one could imagine the ADOs who may have observed an apparent departure).


[here, from ISO:IEC 17025/2005:
4.8 The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).

4.11.5 Where the identification of nonconformities or departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.14 as soon as possible.]


PROBLEM TWO:
There is no statement in CODE Article 7, which allows an ADO or other Signatory to convene any WADA disciplinary procedures for a laboratory's apparent departure that caused the AAF.


PROBLEM THREE:
There is no statement in CODE Article 7, which forces the ADO to reveal an apparent departure that caused the AAF to the Athlete whose test result has apparently been improperly determined.


In Article 8, fair hearings are defined, yet the CODE could simply emphasize that the use of the term 'Person' implicates all Signatories, ADOs, WADA and others who may have violated WADA CODE Articles, by simply redrafting these to be more definitive in the range of 'Person(s)'. This would aid, when matters involving confidentiality or laboratory suspensions are to be properly adjudicated. Further reasons for doing this will appear soon enough, with analyses of Article 13 (below).


WADAwatch has promoted a discussion, that the conflict of
presumptions (Art. 3.2.1) that precede duties, (Art. 6.4) and departures (Art. 7.1 and 7.2) that, once found, are relegated to a judicial no-man's land (No substantive redress; see Problems 1-4), regarding potential laboratory failures are inadequately addressed in the CODE.


Thus it is no surprise that the CODE includes, in a long leap of
unsupportable logic, beyond the pale of normative legal writings, the means in Article 13.5, whereby such laboratories may appeal from their mystery suspensions (apparently only found in the ISL).


PROBLEM FOUR:
The CODE drops the ball by expressing how a laboratory shall appeal a decision taken by WADA to suspend it, after failing to delineate either a) mandatory CODE Articles addressing how ADOs proceed on their justifiable findings of apparent departures, b) in the alternative, clear, precise CODE reference(s) to any relevant ISL Articles on suspensions or revocations.


That leads any legal reader to only one justifiable conclusion: that the sole prerogative to pursue a laboratory resides within the ARBITRARY AND CAPRICIOUS decision of undefined WADA staff.

  • The ADOs have no authority: they cannot address in Article 7 how to proceed on any 'apparent departure'.
  • The IFs don't have the authority also, for much the same grounds.


In-depth study of the WADA ISL shows a presumption on WADA's behalf that solely through failure to perform a WADA Proficiency Test series could a laboratory find itself suspended or dis-accredited by WADA. In ISL Article 4.4.11.2 the listed criteria for suspension omit any input stemming from ADOs or Signatories.

In most large companies, a policy towards employees can have as a model the formula 'three written warnings in 12 months is sufficient grounds for termination'.


Why WADA hasn't seen any substantive reason to render transparent its means for imposing laboratory discipline, is still a
meritorious question.


In this writing, WADAwatch skips over the serious problem of multiple party appeals allowed against a finding in favour of an Athlete, found in Article 13.2.3; a double-jeopardy situation that should be heinous in the concept, is outside the balance of this paper.


Terminating this CODE review, it is imperative to address Article 20, which defines to a degree, the roles and responsibilities of each category of WADA Signatories. Common to every class of Signatory, is the vigorous pursuit sub-Article (eg: Article 20.5.6):


20.5.6 To vigorously pursue all potential anti-doping rule violations within its jurisdiction including investigation into whether Athlete Support Personnel or other Persons may have been involved in each case of doping.


As WADAwatch continues to stress the importance of these
newly-accepted clauses, since their inclusion within each class of Signatory...
(listed: IOC (20.1.7), IPC (20.2.7), IFs (20.3.9), NOC/NPCs (20.4.8), Major Event Sponsors (20.6.5))


... WADA should, by the wording in previous Articles, be establishing a solid legal basis for any Signatory to address the situation of an apparent departure emanating from faulty or negligent laboratory work, since a laboratory qualifies under the WADA Definition of a Person.


But maybe Mr Andersen, Director of the WADA Standardization and Harmonization Committee, is right?


He claimed, over lunch in Madrid, that all the observed lacunae in the CODE addressed by WADAwatch, are found in the CODE's progeny:

do the ISL and IST cure all?


One aspect is readily clear: the words '
apparent departure' do not appear anywhere in the ISL. This casts grave doubts on the ability of the ISL or IST to regulate a problem, when the basic terminology to be regulated is non-existent.


Reading ISL Article 5.3.8 (
Complaints), one sees that an imprecise wording allows for complaint handling to be “in accordance with ISO/IEC 17025:2005 Section 4.8”, however no ISL text regarding who may complain has been expressed. Here, again, are the relevant Articles from ISO/IEC 17025:2005:


[ISO:IEC 17025/2005:
4.8 The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties. Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).

4.11.5 Where the identification of nonconformities or departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.14 as soon as possible.]


PROBLEM FIVE:
One could improve the ISL by expressly including all classes of Signatories that have the power to complain to WADA about shoddy lab work processes or procedures, including leaks of confidential testing results to the press. One could also hope that reference to ISL Article 5.3.8 be expressed in the CODE, to enforce the regularization of the procedures, rights and responsibilities that are shared by WADA's Signatories.


PROBLEM SIX:
One could improve the ISL by expressly delineating the clear steps for WADA to respond to investigation requests of laboratories by its Signatories, to implement those investigations, to render transparent the results of those investigations, and expressing its range of punitive suspensions.


Regarding the lack of usage of 'apparent departure' in the ISL, what does appear in Article 5.3.9, is the phrase 'any non-compliance or procedure'. However, the only application in this context, is regarding a laboratory's internal requirements to document such non-compliance or departures as part of the permanent record for that Sample.


It must be stressed, however, that any improvement to the ISL, without reference from the CODE to such ISL Articles, would be less forceful, than its inclusion within the CODE.


A further reminder, also, that a laboratory that departs from proper procedures, must keep record of that in its permanent record for that Sample. Should that departure cause an AAF, we revert to the problems discussed earlier.


An ADO should be able to do more than 'complain', and the WADA CODE does not express how Signatories can enforce WADA's obligation to investigate these situations. An ADO that proves a 'departure' had caused the AAF, and that the departure came from the laboratory personnel, ought to be able to justify its decision to halt disciplinary action against an incorrectly-accused Athlete, without fearing the ogre of an appeal action by any other potential parties (altered for the 2007 CODE: WADA, IF, IOC, NADO of country of Athlete's residence).


In ANNEX A, Article 3.4.5, WADA finally puts into writing the concepts of 'Overall Laboratory evaluation'. It lists “factors for consideration”, which “include, but are not limited to (eg: false positives, false negatives,... responsiveness to WADA, etc.)”. With this phrasing, the list could be persuasively expanded to include '
apparent departures' or 'non-compliance or departures', and/or complaints pursuant to the ISO/IEC 17025:2005 Section 4.8 procedures, adopted in ISL Article 5.3.8.


SUMMARY

WADA cannot claim to have achieved 'Standardization and Harmonization' concerning laboratory work procedures and results, until it acts to rectify the omissions of laboratory performance control and oversight, through inclusion of the family of Signatories in the manner suggested herein.


Signatory Federations and ADOs, whose reputations are as dependent on these labs as are the Athletes, should request urgent attention to redress these omissions. WADA cannot afford to allow four more years to pass, before bringing laboratories into strict compliance with the current body of WADA regulations that, with these proposed modifications, should offer sufficient controls.


SOLUTION(S)


Notably, WADA could spend more resources in ensuring testing harmonization, through endorsement of machinery performance, test standardization and harmonization, and techniques far beyond its present range of oversight. WADA could endorse even stricter laboratory regulation, which might be seen to have dual motivations: ensuring worldwide testing standardization and harmonization, and ensuring increased support by Athletes for tighter doping regulation.



Let's hope that WADA, is watching (since they could save a pile of money: free legal analysis!),

..........@..........WADAwatch

(link to Part ONE)

2 comments:

jellotrip said...

Hey Zen - I'm wondering if you would lend me a hand in trying to find some information.

The Code v.3 as published had a substantive change in the comment to article 4.2.2, and I'm wondering who suggested the change.

It went from:

"The rules set forth in Article 10.5 would remain the only basis for eliminating or reducing a sanction involving anabolic steroids, hormones, amphetamines, or Prohibited Methods."

To:

"The rules set forth in Article 10.5 would remain the only basis for eliminating or reducing a sanction involving anabolic steroids, hormones, certain stimulants identified on Prohibited List, or Prohibited Methods."

Going from strictly amphetamines, to "certain stimulants" without specifying which ones is a bit deal to me, and I would really appreciate any info that you might have regarding who was behind the change.

In exchange, I could offer you some information about the case I'm involved in.

Nice work on the madrid stuff - and a crazy amount of effort.

Best regards,

Jeff

jeff @ adamsmania.com

johnthep2009 said...

Hi

I like this post very much. It help me to solve some my work under my director’s requirements.

Apart from that, below article also is the same meaning

ISO 17025 standard

Tks again and nice keep posting
Rgs

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